Health product recall

Optipac Refobacin Bone Cement R (2019-12-20)

Starting date:
December 20, 2019
Posting date:
January 10, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72073

Last updated: 2020-01-10

Affected Products

Optipac Refobacin Bone Cement R

Reason

Biomet France Sarl and Biomet Orthopedics Switzerland GmbO are conducting jointly a field safety corrective action for certain optiPac products. Some color variations (different shade of green) of the sterile dot were reported through product complaints. To date, no adverse events have been reported. By means of this field safety notice, Zimmer Biomet would like to inform the users that color variations in the sterile dots do not imply the product's sterility is affected, and that the products can continue to be used within their sterility date. This field safety notice does not require return of
any products.

Affected products

Optipac Refobacin Bone Cement R

Lot or serial number

All lots.

Model or catalog number
  • 4710500394-1
  • 4711500396-1
  • 4712500398-1
Companies
Manufacturer
Biomet SPAIN ORTHOPEDICS S.L.
POLIGONO INDUSTRIAL, "FUENTE DEL JARRO", C/ISLAS BALEARES, 50
VALENCIA,
46988
SPAIN